MAUDE Adverse Event Report: Silk Road Medical ENROUTE Transcarotid Stent; Stent, Carotid

Model Number	FG11815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombus was identified within the stent and the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient passed the neurological check and was taken to the post-anesthesia care unit (pacu).Approximately thirty minutes later, the patient was no longer moving right arm and leg.Imaging revealed no flow through the stent and thrombus in the stent.The patient was taken back to the operating room and shunt was placed.The patient woke up in the operating room and was still unable to move their right arm or leg.Further updates to the patient status were not provided to boston scientific.
Event or Problem Description
It was reported that thrombus was identified within the stent and the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient passed the neurological check and was taken to the post-anesthesia care unit (pacu).Approximately thirty minutes later, the patient was no longer moving right arm and leg.Imaging revealed no flow through the stent and thrombus in the stent.The patient was taken back to the operating room and shunt was placed.Additional information provided indicated that the patient symptoms did not resolve within two weeks post tcar and the patient has since passed away.
Event or Problem Description
It was reported that thrombus was identified within the stent and the patient experienced a stroke.An enroute transcarotid stent was selected for use in a left sided transcarotid artery revascularization (tcar) procedure.Post tcar procedure, the patient passed the neurological check and was taken to the post-anesthesia care unit (pacu).Approximately thirty minutes later, the patient was no longer moving right arm and leg.Imaging revealed no flow through the stent and thrombus in the stent.The patient was taken back to the operating room and shunt was placed.Additional information provided indicated that the patient symptoms did not resolve within two weeks post tcar and the patient has since passed away.
Additional Manufacturer Narrative
B2: date of death was not reported; however, it has been estimated to have occurred in (b)(6) 2026.
Additional Manufacturer Narrative
B2: date of death was not reported; however, it has been estimated to have occurred in (b)(6) 2026.This report is being submitted to correct the type of reportable event field (h1).

• Brand Name: ENROUTE Transcarotid Stent
• Common Device Name: Stent, Carotid
• Manufacturer (Section D): Silk Road Medical; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): CORDIS US CORP; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25538382
• Report Number: 2124215-2026-32408
• Device Sequence Number: 21268291
• Product Code: NIM
• UDI-Device Identifier: 00811311021314
• UDI-Public: (01)00811311021314(17)281031(10)18525886
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG11815
• Device Catalogue Number: FG11815
• Device Lot Number: 0018525886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 07/06/2026; 08/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/31/2026; 09/10/2026
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENROUTE Transcarotid Neuroprotection System.; ENROUTE Transcarotid Neuroprotection System.
• Outcome Attributed to Adverse Event: Other; Death; Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 129 LB